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Active
On-site
Columbus, Ohio
Posted · 20.09.2026
Greenhouse (US)

# Lead GMP Technician, Downstream (2nd Shift)

Forge Biologics

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of&nbsp;H.O.P.E.&nbsp;We are&nbsp;hardworking, showing up each day with determination and grit. We are&nbsp;open, creating a space where ideas flow freely, and every voice is valued. We are&nbsp;purpose-driven, with every task directly tied to changing lives. And we are&nbsp;engaged, energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. About The Role:&nbsp; We are currently seeking&nbsp;a&nbsp;Lead,&nbsp;GMP Manufacturing -&nbsp;Downstream&nbsp;to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the Standard Operating Procedures and Master Production Records for&nbsp;downstream manufacturing processes&nbsp;within Forge’s&nbsp;state-of-the-art&nbsp;cleanroom facility. The role will manage a team of technicians&nbsp;at various levels&nbsp;who implement and perform&nbsp;downstream operations, interacting with clients to complete projects for&nbsp;viral vector purification methods&nbsp;according to client specifications. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.&nbsp; Responsibilities: Lead&nbsp;downstream operations for the purification of viral-based vectors&nbsp;related to gene therapy GMP in a cleanroom environment.&nbsp; Planning and&nbsp;managing for&nbsp;downstream&nbsp;activities, process optimization, and technology transfer to cGMP for&nbsp;viral&nbsp;vectors.&nbsp; Demonstrate&nbsp;proficiency&nbsp;on&nbsp;the specific equipment associated with&nbsp;downstream&nbsp;processes, such as&nbsp;column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.&nbsp; Complete&nbsp;and review&nbsp;documentation concurrently with completion of manufacturing processes.&nbsp; Collaborate with MS&amp;T to support internal process transfer activities from Process Development to GMP.&nbsp; Compile data with minimal oversight&nbsp;to&nbsp;author reports and&nbsp;analyze&nbsp;results for&nbsp;client facing&nbsp;summaries.&nbsp; Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and&nbsp;guidances.&nbsp; Train and mentor&nbsp;junior&nbsp;technicians; perform periodic review of direct reports.&nbsp; Reporting&nbsp;unexpected issues&nbsp;by&nbsp;initiating&nbsp;deviations, participating in investigation,&nbsp;determining&nbsp;root-cause,&nbsp;and implementing CAPA.&nbsp; Partner&nbsp;with&nbsp;the Technical&nbsp;Writing team to draft,&nbsp;revise,&nbsp;and review GMP documentation.&nbsp; Qualifications: 4+&nbsp;years of relevant experience in downstream GMP manufacturing, with&nbsp;additional&nbsp;preference for relevant BS or MS degrees&nbsp;&nbsp; Demonstrated experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography&nbsp;&nbsp; Proficiency&nbsp;in purification processes, such as chromatography, filtration, and centrifugation, with a proven ability to&nbsp;operate&nbsp;and troubleshoot equipment in downstream GMP manufacturing environments&nbsp;&nbsp; Working knowledge of cGMP requirements and biological drug development&nbsp;&nbsp; Must be self-motivating, organized, and proactive&nbsp;&nbsp; Ability to work the hours necessary to support production and/or product transfer activities&nbsp;&nbsp; Ability to work in loud noise environments and in Personal Protective Equipment (PPE)&nbsp;&nbsp; Preferred Skills: Working knowledge of aseptic techniques and automated systems&nbsp;&nbsp; Experience with gene therapy manufacturing and&nbsp;proficiency&nbsp;in using single-use technologies within a GMP downstream processing environment&nbsp; This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.&nbsp; Work Environment and Physical Demands&nbsp;&nbsp; This position works in both a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to&nbsp;identify&nbsp;small details&nbsp;within the field of vision, distinguish between&nbsp;different colors, and accurately&nbsp;identify&nbsp;objects within a specific area. Must be able to lift heavy objects up to 50 lbs.&nbsp;&nbsp; This role requires&nbsp;scheduling&nbsp;flexibility to support GMP manufacturing operations, including the ability to flex hours, work&nbsp;weekends&nbsp;or holidays, and adapt to changing shift assignments based on production demands. Shift schedules may change with limited notice, and work assignments will be&nbsp;determined&nbsp;according to business needs to ensure uninterrupted manufacturing support. The position also requires the ability to complete intermediate mathematical equations, including calculations related to buffer preparation, dilution factors, unit conversions, and process parameter adjustments, performed accurately and consistently&nbsp;in accordance with&nbsp;cGMP expectations.&nbsp; Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.&nbsp; We’ve Got You Covered:&nbsp; At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way: Health from day one Health, dental and vision insurance start your first day – with 90% of premiums covered for you&nbsp;and&nbsp;your family. Time to recharge A competitive paid time off plan – because rest fuels innovation. 12 weeks of fully paid parental leave so you can focus on family when it matters most. Rewarding your impact Annual bonus opportunities for all full-time team members. 401(k) with company match to help you plan for the future. Special employee discounts, including childcare and dependent care savings. Your wellness, supported Onsite fitness facility at The Hearth. Mental health counseling and financial planning services through our Employee Assistance Program. Employer-paid short and long-term disability coverage to protect your peace of mind. Fuel for your workday A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next. Grow with us Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

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